A smarter way to protect your brand A Practical Guide to Stark Compliance Part 1: Stark Law 101: An Introduction to Physician Self- Referral Presented by:
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Physician Self-referral Law: Basics Lisa M. Ohrin, Partner Katten Muchin Rosenman LLP lisa.ohrin@kattenlaw.com (202) 625-3595 4
Disclosure These materials should not be considered as, or as a substitute for, legal advice. They are not intended to nor do they create an attorney-client relationship. Because the materials included here are general, they may not apply to a particular individual legal or factual circumstances. The reader should not take (or refrain from taking) any action based on the information obtained from this document without first obtaining professional counsel. 5
Areas of Governmental Concern Additional Cost Over-, Under-, and Mis-utilization Quality of Care Access to Care Patients Freedom of Choice Competition Exercise of Professional Judgment 6
Fraud and Abuse Issues Statutorily regulated areas of conduct Claims for reimbursement Relationships with referral sources 7
Fraud and Abuse Laws Criminal False Claims Statutes Civil False Claims Statutes Anti-kickback Statute Physician Self-referral Statute Baby Stark Laws (State Level) 8
Physician Self-referral Law Section 1877 of the Social Security Act (42 U.S.C. 1395nn) Regulations found at 42 C.F.R. 411.350 through 411.389 Also referred to as the Stark law 9
History 101: Revisions to the Federal Stark Law Statutory Revisions Requirement that the Secretary promulgate a new exception for e-prescribing items and services (2003) Notice requirement for MRI, CT and PET services furnished by a group practice under the IOAS exception (PPACA, effective January 1, 2011) Physician investment in hospitals (limited by PPACA, effective March 23, 2010) ONLY CHANGES SINCE 1993 EXPANSION TO DESIGNATED HEALTH SERVICES AND THE MEDICAID PROGRAM 10
History 201: The Federal Stark Regulations Proposed Rule 63 FR 41914 January 9, 1998 Phase I Final Rule with Comment Period 66 FR 856 January 4, 2001 Effective Date January 4, 2002 Phase II Interim Final Rule with Comment Period 69 FR 16054 March 26, 2004 Effective Date July 26, 2004 Phase III Final Rule 72 FR 51012 September 5, 2007 Effective Date December 4, 2007 11
History 201: The Federal Stark Regulations Electronic Health Records Proposed Rule 70 FR 59182 Final Rule 71 FR 45140 Proposed Rule October 11, 2005 Final Rule August 8, 2006 Created exceptions for electronic prescribing hardware and software, and electronic health records software, items and services (but not hardware) CY 2008 Physician Fee Schedule Proposed Rule 72 FR 38122 July 12, 2007 Significant proposals for amendments to Stark regulations that feel outside of the scope of the Phase III regulations; solicitation of comments regarding necessity of revising the IOAS exception CY 2008 OPPS Rule Proposed Rule 72 FR 42628, 42792 Final Rule 72 FR 66580, 66851 IPPS FY 2009 Final Rule 73 FR 48434 Proposed Rule August 2, 2007 Final Rule November 27, 2007 Eliminated as DHS: (1) radiological procedures performed immediately before a non-radiological (surgery) procedure; and (2) certain outpatient drugs covered as ancillary services under 42 CFR 416.164(b) August 19, 2008 Effective October 1, 2008 Finalized proposals in the CY 2008 Physician Fee Schedule proposed rule (Provisions regarding per-click and percentage compensation formulae and revised definition of entity effective October 1, 2009) 12
History 201: The Federal Stark Regulations CY 2011 Physician Fee Schedule Proposed Rule 75 FR 40040 Final Rule 75 FR 73170 CY 2011 OPPS Rule Proposed Rule 75 FR 46170 Final Rule 75 FR 72240 Proposed Rule July 13, 2010 Final Rule November 29, 2010 Proposed Rule August 3, 2010 Final Rule November 24, 2010 Implemented IOAS notice provisions required by the Patient Protection and Affordable Care Act Implemented certain provisions related to physician ownership in hospitals, provider agreements and related provisions required by the Patient Protection and Affordable Care Act 13
Audience Polling Question #1 Please indicate the importance of Stark and Physician Compliance among your other compliance priorities (Please select only one answer) 14
Self-referral Prohibition Physician may not refer: Medicare patients for designated health services to an entity with which the physician or an immediate family member has a financial relationship unless the arrangement satisfies the requirements of an applicable exception 15
Self-referral Prohibition Application to Medicaid Section 1903(s) of the Social Security Act No payment shall be made to a State for expenditures for medical assistance under the State plan consisting of a designated health service furnished to an individual on the basis of a referral that would result in the denial of payment for the service under Medicare (if Medicare provided for coverage of the service to the same extent and under the same terms and conditions as under the State plan) Subsections (f) and (g)(5) of section 1877 shall apply to a provider of such a designated health service for which payment may be made under Medicaid in the same manner as such subsections apply to a provider of such a service for which payment may be made under Medicare. Section 1877(f) relates to reporting requirements Section 1877(g)(5) relates to sanctions for failure to report information required under section 1877(f) 16
Sanctions for Noncompliance For Non-Knowing Violations Denial of Payment For Knowing violations (includes failure to make timely refund) Civil Monetary Penalties of $15,000 per item or service plus 2X the amount claimed Civil Monetary Penalties of $100,000 for Circumvention Schemes Exclusion Potential False Claims Act liability 17
Sanctions for Noncompliance CMS is responsible for imposing claims liability Generally, 4-year time limit (from date of initial determination) to reopen and revise claim allowance and take back money; no time limit where allowance was procured by fraud or similar fault OIG is responsible for imposing penalties for knowing violations 6-year time limit (from date of presentment of claim) to impose sanction 18
Sanctions for Noncompliance CMS historically had limited authority to compromise or waive Stark sanctions (or any other claims liability) Under 405.376 claim can be compromised (incl. compromised to 0) only for certain reasons and 405.376 may be amended only with concurrence of DOJ and Treasury With Self-referral Disclosure Protocol, CMS authority has expanded significantly OIG has broad discretion to decide whether to impose CMP/assessment and the amount of CMP/assessment, and whether to impose exclusion and length of exclusion See section 1128A(a) of the Act; 42 CFR Part 1003 19
Key Points Applies only to physicians and immediate family members of physicians Applies only when a financial relationship exists between a physician (or immediate family member of the physician) and an entity furnishing designated health services (DHS) Compliance with an exception is mandatory if the physician makes referrals for DHS to the entity with whom he (or his immediate family member) has a financial relationship Prohibition is limited to referrals for DHS Intent of the parties is irrelevant ( strict liability ) Civil penalties only 20
Designated Health Services Clinical laboratory services Physical therapy services Occupational therapy services Speech language pathology services Radiology services, including MRI, CT, and ultrasound services (also includes nuclear medicine services, effective 1/1/07) Radiation therapy services and supplies 21
Designated Health Services Durable medical equipment and supplies Parenteral and enteral nutrients, equipment, and supplies Prosthetics, orthotics, and prosthetic devices and supplies Home health services Outpatient prescription drugs Inpatient and outpatient hospital services 22
Designated Health Services Inpatient and Outpatient Hospital Services Services that are not on the list of DHS become DHS when furnished as an inpatient or outpatient hospital service Lithotripsy is not considered inpatient or outpatient hospital service Caution: contractual arrangements between hospitals and physicians regarding lithotripsy constitute a financial relationship Must qualify for an exception if the physician refers patients to hospital for inpatient or outpatient services or other DHS If compensation is per-procedure, must be a complete package of services, rather than an equipment lease, in order to qualify for an exception 23
What are not DHS? Most physician services Services paid under SNF PPS Services paid under the ASC payment system Services paid under the ESRD Composite Rate Services that are specifically carved out from the definitions of certain types of DHS Pass-through items or supplies during ASC procedure Radiological procedures to confirm placement of an implant during a non-radiological procedure CT scans for purposes of radiation therapy guidance 24
Key Definitions Referral Requesting, ordering, or certifying the need for DHS Includes a request for a consult and any tests or procedures ordered or performed pursuant to the consult Does not include services personally performed by the referring physician Does include incident to services Referral is imputed to the physician if he directs or controls the person making the referral Preamble includes NPs and PAs in this category 25
Key Definitions Special rules for pathologists, radiologists, and radiation oncologists not a referral if: The pathologist s, radiologist s, or radiation oncologist s request for DHS is made pursuant to a request for a consultation Initiated by another physician Documented on the patient s chart Followed with a written report Test or service is performed by or under the supervision of the consulting physician Supervision requirement met if the test or service is supervised by a pathologist, radiologist, or radiation oncologist in the same group practice as the consulting physician 26
Key Definitions Entity Includes Person or entity that has performed services that are billed as DHS Person or entity that has presented a claim to Medicare for the DHS Person or entity to which the right to payment for the DHS has been reassigned Health plan, MCO, PSO, or IPA that employs a supplier or operates a facility that could accept reassignment from a supplier (with respect to DHS furnished by that supplier) Does not include Physician practice when it bills Medicare for the technical component (TC) or professional component (PC) of a diagnostic test in accordance with the anti-markup payment limitation rules in 414.50 27
Key Definitions Financial Relationship May be ownership/investment interest or compensation arrangement May be direct or indirect 28
Key Definitions Ownership or Investment Interest Includes equity, debt, and other means Does not include Interest in a retirement plan Stock options earned as compensation until exercised Unsecured loans Under arrangements contracts Security interest held by a physician in equipment sold by the physician to a hospital (when financed through a loan to the hospital) 29
Key Definitions Direct ownership/investment interest exists between the referring physician (or a member of his or her immediate family) and the DHS entity if there are no intervening persons or entities between them 30
Key Definitions Indirect ownership/investment interest Between the physician and the entity furnishing DHS, there exists an unbroken chain of any number ( 1) of persons or entities having ownership or investment interests DHS entity has actual knowledge (or reckless disregard or deliberate ignorance) of the physician s ownership or investment interest The DHS entity need not know precise composition of chain Common ownership does not create indirect ownership B A C indirect ownership interest for B in C or vice versa 31
Key Definitions Compensation Arrangement Any arrangement involving remuneration, direct or indirect, between a physician (or a member of a physician s immediate family) and an entity. Includes contracts between hospitals and entities providing DHS under arrangements to the hospital Does not include the portion of any business arrangement that consists solely of remuneration described in section 1877(h)(1)(C) of the Act 32
Key Definitions Direct Compensation Arrangements Any arrangement involving remuneration between a DHS entity and a referring physician (or immediate family member) No person or entity interposed between them Deemed Direct Compensation Arrangements Stand in the Shoes Provisions Physician is deemed to have a direct compensation with a DHS entity if he or she has an ownership interest in his or her physician organization Does not apply to titular ownership The physician is deemed to have the same compensation arrangements (with the same parties and on the same terms) as the physician organization 33
Key Definitions Indirect Compensation Arrangements Between the referring physician and the DHS entity, there is an unbroken chain of any number of entities ( 1) that have financial relationships (either ownership/investment interests or compensation arrangements) Aggregate compensation to the physician from the closest link in the chain varies with or takes into account the volume or value of referrals to or other business generated by the physician for the entity providing DHS Entity providing DHS has actual knowledge or acts in reckless disregard or deliberate ignorance of the existence of such relationship 34
Key Definitions Indirect Compensation Arrangements Stand in the Shoes Provisions For purposes of determining whether an indirect compensation arrangement exists, a physician is deemed to stand in the shoes of his or her physician organization if he or she has an ownership interest in the physician organization Does not apply to titular ownership The physician is deemed to have the same compensation arrangements (with the same parties and on the same terms) as the physician organization 35
Key Definitions Set in Advance Flat amount of aggregate compensation Amount is based on unit-of-time or unit-of-service (includes per-use and per-service); or Specific formula for calculating the compensation Includes percentage compensation formulae Formula must be in sufficient detail so that it can be objectively verified May not be modified during the course of the agreement in any manner that takes into account the volume or value of referrals or other business generated by the referring physician Must be set in an agreement between the parties before the furnishing of items or services for which the compensation is paid 36
Audience Polling Question #2 Relative to Stark and Physician Compliance, which of the following are most challenging for your organization? (Please select only one answer) 37
Exceptions to the Stark Law Generally, there are three types of exceptions: Ownership/investment interests ( 411.356) Compensation arrangements ( 411.357) Services (applicable to both ownership/investment interests and compensation arrangements)( 411.355) Other exceptions ( 411.353) Knowledge exception for payments made to an entity that did not have actual knowledge of, and did not act in reckless disregard or deliberate ignorance of, the identity of the physician who made the prohibited referral for DHS Temporary noncompliance 38
Ownership Exceptions Publicly-traded securities Held in corporations with equity exceeding $75,000,000 Mutual funds Total assets exceeding $75,000,000 Rural Providers Substantially all ( 75 percent) of DHS furnished is furnished to residents of a rural area Hospital located in Puerto Rico 39
Ownership Exceptions Whole Hospital exception Referring physician must be authorized to perform services at the hospital Ownership or investment interest may not be merely in a distinct part or department of the hospital Must meet the requirements imposed by the Affordable Care Act and implementing regulations by September 23, 2011 Requirements found in 411.362 Provider agreement in place by December 31, 2010 Prohibition on facility expansion Disclosure of conflicts of interest Bona fide investment Patient safety Cannot convert from ASC 40
Statutory Compensation Arrangement Exceptions Rental of Office Space Rental of Equipment Bona Fide Employment Relationships Personal Service Arrangements Certain Physician Incentive Plans Physician Recruitment Certain Arrangements with Hospitals (remuneration unrelated to DHS) Group Practice Arrangements with a Hospital Payments by a Physician Electronic Prescribing Items and Services (section 1860D- 3(e) of the MMA) 41
Compensation Arrangements Exceptions Established using the Secretary s authority under section 1877(b)(4) of the Act Charitable Donations by a Physician Nonmonetary Compensation Fair Market Value Compensation Medical Staff Incidental Benefits Risk-sharing Arrangements Compliance Training Indirect Compensation Arrangements Referral Services Obstetrical Malpractice Insurance Subsidies Professional Courtesy Retention Payments in Underserved Areas Community-wide Health Information Systems Electronic Health Records Items and Services 42
Issues Related to Exceptions for Compensation Arrangements Per-click leases and percentage based compensation formulae Applies to office space and equipment leases Limitations in exceptions for rental of office space, rental of equipment, fair market value compensation and indirect compensation arrangements Written agreements Not necessary for employment, payments by a physician Privity of contract Correcting noncompliance Applies only to nonmonetary compensation 43
Per-click and Percentage Compensation Limitations Per-click compensation Compensation may not be determined using a formula based on per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred by the lessor to the lessee Original text noted referrals between the parties ; corrected at 73 Fed. Reg. 57541 (Oct. 3, 2008) Corrected in e-cfr for office space rental, but e-cfr remains incorrect for equipment rental, fair market value compensation, and indirect compensation arrangements Where hospital is lessor and does not make referrals to the physician (or physician group) lessee, per-click rental charges remain permissible Where physician (or physician group) is lessor, per-click rental charges are prohibited, unless the physician (or any physician group owner) does not makes referrals to the hospital that affect the rental charges paid to the physician (or physician group) lessor Through preamble language, CMS intends to make this applicable to physicianowned lessors, regardless of whether they are physician organizations in which the physician owner stands in the shoes See 73 Fed. Reg. 48720 (Aug. 19, 2008) 44
Per-click and Percentage Compensation Limitations Percentage-based compensation Limitation on use of percentage-based compensation formulae for rental of office space and equipment All other use is permissible, provided that the requirements of the regulations are satisfied Compensation may not be determined using a formula based on a percentage of the revenue raised, earned, billed, collected or otherwise attributable to the services performed or business generated in the office space or through the use of the equipment Does not matter whether physician (or physician group) is lessor or lessee 45
Services Exceptions Physician Services In-office Ancillary Services Services Furnished by an Organization (or its Contractors or Subcontractors) to Enrollees (prepaid health plans) Academic Medical Centers Implants Furnished by an ASC EPO and Other Dialysis-related Drugs Preventive Screening Tests, Immunizations, and Vaccines Eyeglasses and Contact Lenses Following Cataract Surgery Intra-family Rural Referrals 46
In-office Ancillary Services Exception Available to group practices (by definition at 42 C.F.R. 411.352) and physicians in solo practice Applies to ALL services (except most DME) Three main requirements Who Who performed or supervised the service? Location Centralized building or same building Billing In whose name and billing number was the service billed? 47
In-office Ancillary Services Exception Notice Requirement Applies only to MRI, CT and PET services furnished on or after January 1, 2011 Must include at least 5 (or as many that exist if less than 5) other suppliers Within a 25-mile radius of the physician s office location at the time of the referral Not tied to the location of the patient s residence (as stated in PPACA) or necessarily to the location at which the DHS will be furnished Group practice/physician may choose which suppliers to include Need not include any available providers of services (e.g., hospitals) Must include name, address and phone number for each listed supplier No notice required if there are no alternative suppliers within a 25-mile radius of the physician s office location 48
Grace Periods 42 C.F.R. 411.353(g) Provided that all other requirements of an exception are satisfied, if the parties failed to obtain a signature at the commencement of the arrangement, the arrangement will be considered compliant from its commencement if the signature is obtained within 30 days if the failure was knowing 90 days if the failure was inadvertent The grace period may be used by an entity only once every 3 years with respect to the same referring physician 49
Common Practices and Arrangements that Implicate the Stark Law Parking, discounted cafeteria meals, lab coats, etc. Referrals to other physicians in a medical practice Office space leases on a hospital s campus Answering service provided by the hospital Participation in golf tournaments Tickets to sporting events, symphony, etc. Holiday parties and gifts Employment of a physician s spouse in the HR department of the hospital Hospital purchase of services from physician-owned company 50
Anti-kickback Statute: Key Differences Applies to any individual or legal entity Applies to all items and services for which payment may be made, in whole or in part, under a federally funded health care program Compliance with a safe harbor is not mandatory, though it is preferred Knowing and willful intent standard; case law includes one purpose test Penalties include criminal penalties, civil money penalties, and exclusion, and apply to all parties where proof of intent exists 51
Audience Polling Question #3 Would you like to learn how Katten Muchin Rosenman LLP or Compliance 360 can help you with Stark and Physician Compliance, or other compliance related matters? (Please select all that apply) 52
Coming Attractions: Upcoming Compliance 360 Webcasts: Webcast: Part 2: Stark Law Compliance Tips and Practical Guidance With: Lisa Ohrin, Katten Muchen Rosenman LLP Date: Wednesday, June 1 st,, 2011 Time: 2:00-3:00 pm ET Cost: FREE REGISTER AT: www.compliance360.com/webinars 53